EU approves Roche's Perjeta, Humer to step down in 2014

As expected, regulators in Europe have given the green light to Roche's Perjeta as a treatment for breast cancer.

The European Medicines Agency has approved Perjeta (pertuzumab) in combination with Roche's blockbuster Herceptin (trastuzumab) and docetaxel in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy. The approval comes after the agency's Committee for Medicinal Products for Human Use issued a positive opinion on the combo in December; it was approved in the USA in June last year.

The thumbs-up is based on data from the Phase III CLEOPATRA trial which showed that the combination of Perjeta, Herceptin and chemotherapy provided patients with a median of 6.1 months longer without their disease worsening or death (progression-free survival) and provided a 34% reduction in the risk of death (overall survival) compared to Herceptin and chemotherapy alone. Roche's chief medical officer, noted that the combo is the first to significantly extend survival compared to the previous standard of care.

Meantime, Roche's chairman Franz Humer has told told attendees at the company's annual general meeting that he will not stand for re-election next year.

The industry veteran, 66, said that "Roche is in excellent shape and well positioned to meet future challenges. This is a good time to hand over to a successor". The Swiss major said it will nominate a replacement in autumn and some observers believe Art Levinson, the current chairman and ex-chief executive of Roche's Genentech unit – and also current chairman of Apple – may be offered the job.